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Properties

Steps (61) arrow_drop_up arrow_drop_down
Register with Pharmacy and Poisons Board (PPB) online service portal  (3) expand_more expand_less
Obtain wholesale dealer's licence and certificate of premise registration  (6) expand_more expand_less
Register with KESWS  (4) expand_more expand_less
Obtain drug sample permit  (3) expand_more expand_less
Drug sample clearance  (6) expand_more expand_less
Obtain certificate of analysis  (4) expand_more expand_less
Obtain certificate of good manufacturing practices  (5) expand_more expand_less
Obtain product registration certificate  (4) expand_more expand_less
Obtain pharmaceutical import permit  (5) expand_more expand_less
Obtain import declaration form  (2) expand_more expand_less
Pre-clearance documentation  (1) expand_more expand_less
Obtain passed clearance entry  (3) expand_more expand_less
language
language
Enter the OSBP  (1) expand_more expand_less
Obtain PPB release  (2) expand_more expand_less
Obtain Port Health Services release  (6) expand_more expand_less
Obtain KEBS release  (2) expand_more expand_less
Obtain KRA release  (3) expand_more expand_less
Obtain KRA final release  (1) expand_more expand_less

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Summary of the procedure

Institutions involved 13 expand_more expand_less

Pharmacy and Poisons Board (PPB) Online Services Portal (x 2)
Pharmacy and Poisons Board (PPB) Trade Portal (x 4)
Kenya Trade Network Agency (KenTrade) (x 3)
Kenya Electronic Single Window System (KESWS) (x 9)
Courier Service Provider (x 5)
Mission for Essential Drugs Supplies (MEDS) (x 4)
Clearing Agent
Kenya Revenue Authority (KRA), One Stop Border Post (OSBP) (Isebania) (x 5)
Pharmacy and Poisons Board (PPB), One Stop Border Post (OSBP) (Isebania) (x 2)
Port Health Services Kenya, One Stop Border Post (OSBP) (Isebania) (x 3)
Kenya Bureau of Standards (KEBS), One Stop Border Post (OSBP) (Isebania) (x 2)

Results 13 expand_more expand_less

User credentials
Wholesale dealer's licence
Certificate for registration of premises
Annual practice licence for pharmacists
User credentials
Drug sample
Certificate of analysis
Certificate of good manufacturing practices
Product registration certificate
Commercial medicines import permit
Import declaration form (IDF)
Passed clearance entry stamped released by KRA
Cargo manifest stamped released by KRA

Required Documents expand_more expand_less

Identity card
Company PIN certificate (x 2)
Individual PIN certficate
List of shareholders (Form CR-12)
Certificate of incorporation (x 3)
Form CR 2
Academic qualification
Request for company registration
Company PIN
Wholesale dealer's licence (x 4)
Invoice
Drug sample permit
Bank deposit slip
Sample analysis request
Laboratory client registration form
Test request form
Certificate of analysis
Site master file (x 2)
Pharmacy and Poisons Board (PPB) invoice (x 4)
Pharmacy and Poisons Board (PPB) receipt (x 3)
Certificate of good manufacturing practices authorization letter
Application for registration of a drug - Form 1
Certificate of analysis (x 2)
Certificate of good manufacturing practices
Certificate of pharmaceutical product
Product registration certificate (x 3)
Submitted commercial medicines import permit
Authorization for payment for commercial medicines import permit (x 2)
Permit (x 2)
Certificate of conformity (COC) (x 2)
KRA e-slip
Passed clearance entry (x 7)
Commercial medicines import permit
Certificate of analysis
Proforma invoice
Packing list (x 3)
Phytosanitary certificate
Plant import permit
Certificate of quality (x 2)
Food hygiene licence
EAC certificate of origin form
Import declaration form (IDF)
Certificate of export
Cargo manifest (C2)
Preferential certificate of origin
Passed clearance entry stamped by verification officer
Cargo manifest stamped by verification officer
Passed clearance entry stamped release by KRA
Cargo manifest stamped released by KRA

Estimated cost KES  91,750 +USD  4,000

expand_more expand_less

KES expand_more expand_less
  • KES Add Name Here
This is an estimate based on a series of assumptions which you can modify to calculate your own costs:

Cost detail

Estimate your cost

KES 30,000
For wholesale dealer licence.
KES 10,000
For certificate of registration of premises.
KES 5,000
For annual practice licence for a pharmacist.
KES 250
For airline concession fees.
KES 800
For KEBS inspection. For goods worth KES 50 000 and below.
KES 1,200
For KEBS inspection. For goods worth KES 50 001 - KES 100 000.
KES 1,500
For KEBS inspection. For goods worth KES 100,001 - KES 500,000.
KES 0 -
1.5 % goods-value
For KEBS inspection. For goods worth KES 500,000 and above.
KES 0 -
KES  25 per kilogram
per day
KES 0 -
KES  35 per kilogram
per day
KES 0 -
KES  55 per kilogram
per day
KES 42,000
For sample analysis - estimate.
USD 4,000
For a certificate of good manufacturing practices.
USD 0 -
USD  1,000 per product
For product registration, for foreign products.
KES 0 -
0.75 % Free on board (FOB)
KES 0 -
1 % goods-value
Clearing agent fees - estimate.
KES 0 -
2 % Cost, Insurance & Freight (CIF) or customs value
Railway development levy.
KES 0 -
3.5 % Cost, Insurance & Freight (CIF) or customs value
For import duty.
KES 1,000
For issuance of import health certificate.

Total Duration 184d - 957d  expand_more expand_less

  Min. Max.
Total time (sum): 184d 957d
of which:
Waiting time in queue (sum): 2h. 10mn 6h. 20mn
Attention at counter: 5h. 15mn 2d
Waiting time until next step (sum): 183d 954d

Laws 23 expand_more expand_less

COMESA Rules of Origin COMESA Protocol on the Rules of Origin
Customs and Excise Regulations Customs and Excise Regulations (2010) Part XI
  Sections 14, 15, 25, 30, 127C, 127, 128B, 199
Drug registration - Guidelines to submission of applications Drug registration - Guidelines to submission of applications
East Africa Community Common External Tariff 2017 East Africa Community Common External Tariff 2017
East African Community Customs Management Act (2004) East African Community Customs Management Act (2004)
  Sections 34, 35, 36, 38, 41, 82, 123, 145, 146, 187, 188, 189, 235
East African Community Customs Management Regulations, 2010 East African Community Customs Management Regulations (2010)
  Sections 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 187
Finance Act 2019 Finance Act 2019
  Section  6
Food, Drugs and Chemicals (General) Regulations Food, Drugs and Chemical Substances (Food Hygiene) Regulations, 1978
  Sections 8, 10